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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00802126
Other study ID # 81613
Secondary ID
Status Completed
Phase Phase 1
First received December 2, 2008
Last updated February 5, 2016
Start date November 2007
Est. completion date May 2009

Study information

Verified date February 2016
Source Second University of Naples
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to report the treatment effect and safety of combined intravitreal bevacizumab (IVB) and photodynamic therapy (PDT) with verteporfin using a reduced (RF) light fluence rate, in choroidal neovascularization (CNV) secondary to pathologic myopia.


Description:

In this retrospective interventional case series, 16 patients with myopic CNV were included. All patients were treated with 1.25 mg of intravitreal bevacizumab followed by RF-PDT (25 J/cm²), 2 days later. All patients were previously treated with IVB monotherapy and active leaking of CNV occurred 90 to 120 days after the treatment.

Best-corrected visual acuity (BCVA-ETDRS), foveal thickness (FT) on optical coherence tomography (OCT), and fluorescein and indocyanine green angiographic (FA; ICG) findings were recorded. Follow-up evaluations were carried out for 12 months.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date May 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 60 Years
Eligibility Inclusion Criteria:

- Myopic CNV, CNV leakage

Exclusion Criteria:

- CNV not associated with high myopia

- No activity of CNV

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Combination therapy "IVB + rf-PDT"
low-fluence photodynamic therapy combined with intravitreal bevacizumab

Locations

Country Name City State
Italy Ophthalmology Department SUN Napoli

Sponsors (1)

Lead Sponsor Collaborator
Second University of Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary BCVA improved 6 months Yes
Secondary no CNV leakage 6 months Yes
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